FDA Inspection
ACS Dobfar S.p.A.ACS Dobfar S.p.A. – FDA Inspection, Jul 21, 2017
Record Details
This FDA Inspection record concerns ACS Dobfar S.p.A., with an inspection on July 21, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 584779c1-9978-4f42-ac8d-32841973f716
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1019162
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.84(d)(2)Component identification test
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Other FDA inspections of ACS Dobfar S.p.A.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 8, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 13, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 19, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 23, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 27, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ACS Dobfar S.p.A.
- FDA Inspection 1203381 - 2022-04-08
- FDA Inspection 1123735 - 2018-04-13
- FDA Inspection 955350 - 2016-01-19
- FDA Inspection 881223 - 2014-05-23
- FDA Inspection 777346 - 2012-03-27
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